April 13, 2021
Sound Biologics Announces Proof-of-Concept Success at AARC Annual Meeting
Phase 1 Study results for PSB205, a bifunctional anti-PD-1 and anti-CTLA-4 MabPair product, provides proof-of-concept and early clinical validation of the MabPair platform
BOTHELL, Wash., April 13, 2021 /PRNewswire/ — Qilu Puget Sound Biotherapeutic Corp. (Sound Biologics), an emerging biotechnology company focused on developing a novel MabPair™ platform for antibody-based combination therapies for the treatment of cancer, inflammation and autoimmune disease, announced a clinical update on its first MabPair product PSB205 at the American Association for Cancer Research (AACR) Annual Meeting. Dr Li Zhang of Sun Yat-Sen University Cancer Centre (SYSUCC), Guangzhou, China presented a poster on Phase 1 Clinical Trial results of PSB205, a combination of anti-PD1 and anti-CTLA-4 antibodies that are manufactured together as a single product, in patients with advanced malignant tumors. The study is sponsored by Qilu Pharma in China.
Details of the presentation:
Presentation Title: Development and Preliminary Clinical Activity of QL1706 (PSB205), a Combination of anti-PD1 and anti-CTLA-4 Antibodies Manufactured Together as a Single Product
Session Title/Category: Phase I Clinical Trials
Session Type: E-Poster Session, 8:30 AM – 11:59 PM, Saturday, April 10
Poster Number: CT119
Forty-seven patients, 95% of whom had refractory Naso-Pharyngeal (NPC) or lung (NSCLC) cancers, were enrolled at a single clinic with over 5 ascending dose levels in a standard 3+3 design. A dose of 5 mg/kg was selected for continued clinical development. The most common side effects were Grade 1 pruritus and rash. Dose-limiting immune-related reactions occurred only at doses higher than 5 mg/kg. The Overall Rate of Response (ORR) was 29% among 35 patients evaluable for tumor response; among 20 patients without prior exposure to checkpoint-targeted immunotherapy, 40 % achieved Partial Response (PR), whereas 2 of 10 patients (20%) previously treated and progressed on earlier immunotherapy realized PR. For 5 patients on study, pre-study checkpoint inhibitor exposure status was unknown due to earlier participation in a still-blinded randomized immunotherapy trial.
“The Phase 1 data presented at AACR provides encouraging proof-of-concept and early clinical validation of the MabPair platform,” commented Sound Biologics’ Chief Executive Officer Wei Yan, PhD. “The early data offer multiple opportunities for further development of this dual immune checkpoint blockade product.”
PSB205 is a first-in-class bifunctional product that contains a mixture of unique anti-PD-1 and anti-CTLA-4 monoclonal antibodies produced by a single cell line via the company’s proprietary MabPairTM technology. MabPair products offer many advantages over bispecific antibodies. The relative ratio of the two antibodies in the MabPair can be well controlled, and each antibody is individually engineered for optimal target coverage, effector function, pharmacokinetics and exposure. The anti-CTLA-4 component of the MabPair is designed with a shorter half-life than currently available anti-CTLA-4 antibodies in an effort to reduce known side effects associated with CTLA-4 blockade. Preclinical studies with PSB205 demonstrated superior efficacy in tumor models compared to either checkpoint inhibitor alone. PSB205 represents a potentially best-in-class immuno-oncology product that promises to exhibit robust combination activity while being significantly more tolerable to patients than currently approved anti-PD-1/anti-CTLA-4 combinations. Parallel Phase 1 studies in a broad range of refractory solid tumors are currently ongoing in China and the United States (www.clinicaltrials.gov; NCT03986606), and the AACR poster represents the first release of clinical data from one of these studies.
Contact: Sound Biologics
Wei Yan, Ph.D.
Chief Executive Officer
Jelle Kijlstra, MD, MBA
Chief Medical Officer